India Offers Biopharma Opportunities and Challenges
An established drug-manufacturing base with quality and safety issues, and patent protection and price capping concerns complicate efforts to do business in India.
Are CMOs Out of Synch With Market Realities?
Why can't the CMO industry break through to manufacture a greater share of drugs?
Key Considerations for Quality-Technical Agreements
A drug sponsor?s responsibility does not end when a task is outsourced.
Defining Quality Metrics to Ease Drug Shortages
Industry players and FDA evaluation possible quality metrics to improve manufacturing efficiencies and avoid drug shortages.
Cocrystals: Industry Takes a Wait-and-See Approach
The perceived risks associated with cocrystals may be slowing progress of their industrial application.
DCAT Sharp Sourcing Addresses Procurement Topics
DCAT's Sharp Sourcing 2014 educational program offers pharmaceutical and biopharmaceutical companies a forum to gain best practice insights in sourcing and procurement.
FDA Expands CERSI Network
John Hopkins and UCSF-Stanford join FDA?s Centers of Excellence in Regulatory Science and Innovation.
HPAPIs: Fast-growing Segment Presents Challenges and Opportunities
Appropriate process design and engineering are critical for the production of small-molecule and biologic HPAPIs.
Turkish Pharma Manufacturers Look to New Markets
The CPhI report warns that Turkey's dynamism is being restricted by the current government reimbursement model.
Lilly Oncology On Canvas Celebrates 10 Years of Cancer Journeys
ASCO meeting attendees give artistic interpretations of cancer journeys in the form of public Hope Murals.
BioPlan Associates Releases 11th Annual Global Biomanufacturing Study
The 11th Annual Global Biomanufacturing Study includes a global analysis of 238 biomanufacturers and 178 suppliers in 31 countries.
BPTF Warns FDA on Reduced API Manufacturer Inspections
The Bulk Pharmaceuticals Task Force asks FDA to respond to concerns about reduction in API facility compliance inspections.
EquipNet Celebrates 15 Years of Asset Management
EquipNet announced its 15th year of supplying asset management services.
DPx Holdings B.V. Donates to Hospitals and Organizations
DPx Holdings B.V. donated $110,000 to more than 20 different hospitals and organizations across the globe.
Gnosis Receives CEP Certification for Teicoplanin
The EDQM grants Gnosis a CEP for teicoplanin, a true fermentation glycopeptide antibiotic produced by actinoplanes teichomyceticus strains.
Pfizer and Avon Announce Metastatic Breast Cancer Program
Pfizer and the Avon Foundation for Women Breast Cancer Grants Program will award up to $1 million in grants to advocacy, academic, and other not-for-profit organizations.
Avantor Performance Materials Names New CEO
Avantor Performance Materials appoints Michael Stubblefield as CEO.
GSK Announces Vaccine Price Freeze in Support of GAVI Alliance
GSK reports 5-year vaccine price freeze for countries graduating from GAVI Alliance.
Brookfield Marks 80 Years of Laboratory Technology
Brookfield continues to supply viscometers and rheometers for laboratory and on-line process control applications.
SAFC Installs Continuous-Flow Reactor
SAFC offers commercial and pilot-scale continuous-flow capacity.
SGS Announces Appointments at New Facility in California
SGS makes two senior appointments at its new GMP/GLP laboratory in Carson, California.
EMA and European Chemicals Agency Strengthen Collaboration
EMA and ECHA sign agreement to share information and work together on risk assessments.
Novasep Commissions Plant Extension for Highly Potent APIs
New manufacturing capacity at the Le Mans, France facility is being used to scale up antibody drug conjugates.
